Strong history of stem cell research in Canada

Stem cell concept defined by Leblond (Montreal) and Till and McCulloch (Toronto) in 1960s and 70s

Hematopoetic stem cell heritage– 11/19 classic stem cell papers(1960-1980)

authored by Canadians (Nature Immunol. 2002)

Recent Canadian discoveries in stem cell science

Neural stem cells from adult brain (Weiss, Calgary) Retinal stem cells (van der Kooy, McInnes, Toronto) Skin-derived stem cells (Miller, Montreal/Toronto) Muscle stem cells redefined (Rudnicki, Ottawa) ES cell potential to make mice (Nagy/Rossant,

Toronto) Expansion of hematopoetic stem cells (Sauvageau,

Montreal; Humphries, Vancouver; Bhatia, London)

Translation to therapy

Strong research environment in ethical, legal and social issues regarding stem cells

Leaders in stem cell and tissue bioengineering

Excellence in clinical transplant protocols– Fetal tissue transplants for Parkinson’s (Mendez,

Halifax)– Islet transplantation for diabetes (Shapiro,

Edmonton protocol)

Regulation of stem cell research in Canada Tri-Council Policy Statement: Ethical Conduct

for Research Involving Humans includes general guidelines for research on human embryos and fetal material (1998)

CIHR guidelines (March 2002) Bill C-56 (May 2002), re-named C-13 in

October 2002

CIHR research guidelines:guiding principles

Free and informed consent with full disclosure

Respect for privacy and confidentiality No direct or indirect payment or

financial incentives

ES cells from “spare” IVF embryos Embryonic germ cells from fetal tissue Stem cells from amniotic fluid Umbilical cord and placenta Somatic tissues

Fundable research: derivation of stem cells

Research on existing human pluripotent stem cell lines– Provided they are created according to CIHR

guidelines Chimera research

– Grafting of human stem cells into non-human animals from birth to adult, under certain conditions

– Grafting of human stem cell lines into legally competent humans, under certain conditions

Other fundable research

Not eligible for funding

Creation of embryos for research purposes Nuclear transfer (cloning) to create embryos

for stem cell derivation Directed donation of stem cell lines unless for

autologous donation Chimeras: experiments involving human

embryos and fetuses, or animal embryos and fetuses with human stem cells

Consent process

1. Options for excess embryos must be discussed with gamete providers and embryo providers (if these are different), and a decision made, prior to gamete collection.

2. Consent must be confirmed when research begins. If gamete providers are not the same as embryo providers, and unrestricted consent was given at the time of donation, renewal is not required.

3. Fetal tissue: research option discussed only after free and informed choice to have an abortion.

Voluntariness

1. The physician responsible for fertility treatment, and the person seeking consent to use embryos, may not be part of the stem cell research team.

2. Re-confirmation of consent at time of research use (except gamete providers when not the same as embryo providers).

3. Consent revocable (except gamete providers when not the same as embryo providers) until anonymized cell line created.

4. No pressure from researchers to produce excess embryos.

5. Consent to research never a condition of access to treatment.

Ethics review: Stem Cell Oversight Committee

National oversight body: rationale– Accountability, public confidence– Expertise to review specialized research– Minimize potential for conflict of interest

Review process– CIHR peer review National oversight REB– National oversight body and REB must both

approve Oversight body accountable to the Governing

Council of CIHR

Bill C-13: An Act respectingassisted human reproduction Regulates IVF procedures and all other embryo

manipulation and research Principles:

– Protection and promotion of human health, safety, dignity and rights in the use of reproductive technologies and in related research

– Human individuality and diversity and integrity of the human genome

C-13 applies to all research in Canada and takes precedence where CIHR guidelines and the legislation conflict. CIHR guidelines apply only to CIHR-funded research.

Bill C-13: Prohibitions relating to research Creating an embryo for research Therapeutic cloning Germline alteration of embryos Creation of chimeras (animal to human) Purchase of in vitro embryos

Bill C-13: Controlled Activities Relating to Stem Cell Research Manipulation of embryos (i.e. creation of

stem cell lines) Importing and exporting embryos

Other Aspects of Bill C-13

Privacy, health reporting information, and access to information

Details on how the Agency will operate 3 year Parliamentary review “Grandfather” clause provision

Comparison of Canadian Regulatory Frameworks

  CIHR C-13

Creating research embryos No No

Cloning (nuclear transfer) No No

Cloning (reproductive) No No

Germline genetic alteration   No

Chimera (aSC or hSC + hum. emb.) No No

Chimera (aSC or hSC + hum. fetus) No  

Chimera (hSC + an. embryo No  

Chimera (hSC + an. fetus) No  

Hybrids   No

Existing hum. ES cell lines Yes*  

Deriv. of SC from spare IVF emb. Yes* Yes*

Deriv. of SC from fetal material Yes*  

Note: * = with conditions

Stem Cell Network

An independent, not-for-profit corporation Funded for $21 million over four years Part of federal government’s Networks of

Centres of Excellence Program

Network research program

Stem cell characterization– Cell biology, plasticity, genomics, proteomics

Ethical, legal, and social framework development Interdisciplinary team approaches to new

therapies– Diabetes– Neurodegeneration– Stroke– Cardiac disease– Muscular dystrophies

Network activities

Fund large collaborative, multi-disciplinary, multi-institutional research projects

Provide advice and support to universities on commercializing stem cell research

Run a national stem cell training initiative Act as the voice of science in the legislative

process Develop industrial, NGO, and government

partnerships for academic stem cell research

Stem cell funding in Canada

Multiple sources:– CIHR– Stem Cell Network– Genome Canada– NIH– Health Charities

~$20 million in 2001/02 to Network labs ~$50 million already committed through 2004/2005 Start-up and established companies with stem cell

focus